Pharmacovigilance Operations Manager
About the role
The PV Operations Manager will oversee clinical trial safety operations, manage external safety vendors, and maintain an inspection-ready PV system.
Responsibilities
Manage relationships with external safety vendors, including CROs and case processing providers.
Monitor vendor performance through KPIs and quality metrics; implement corrective actions as needed.
Support compliance with SOPs, regulatory guidelines, and company policies.
Participate in audits and regulatory inspections, providing documentation and subject matter expertise.
Collaborate with Clinical Operations, Regulatory Affairs, Quality Assurance, and other stakeholders to ensure seamless safety data flow.
Contribute to safety governance meetings and provide operational input on risk management plans and safety strategies.
Identify opportunities for process optimization and implement best practices in PV operations.
Maintain accurate documentation of PV activities, including safety management plans and vendor oversight plans.
Provide training and guidance to internal teams and vendors on PV processes and compliance requirements.
Qualifications
Bachelor’s degree in life sciences or related field; advanced degree preferred
Minimum 5 years of experience in pharmacovigilance operations within clinical development
Strong knowledge of global PV regulations (ICH, FDA, EMA, etc.)
Experience managing external vendors and ensuring compliance with contractual obligations
Excellent organizational, communication, and problem-solving skills
Ability to work independently in a remote environment and travel quarterly to corporate offices